Kornimate/medical-research-clean huggingface dataset:
phase i clinical trial of a candidate herpes zoster vaccine

Conditions: Herpes Zoster

Summary: this is a phase i, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of bv211(a herpes zoster vaccine) in adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy resident aged 30-70 years with body weight ≥ 50 kg for males and ≥ 45 kg for females, bmi within the range of 19.0-32.0 (including the boundary value), who can provide legal identification. * willing to participate in the study and sign icf. * women of childbearing age shall take effective contraception measures 30 days before vaccination up to 6 months post full vaccination and not in lactation period. the pregnancy test on the day of vaccination shall be negative. * will attend all scheduled follow-up visits and follow the requirements of the clinical study. exclusion criteria: * smoking, and/or excessive alcohol use. * failed the screening test of illicit drugs, including thc. * axillary temperature above 37.3℃. * history of herpes zoster. * received any herpes zoster vaccine. * received any vaccine within 14 days or live vaccine within 28 days before vaccination. * received gamma immunoglobulin or intravenous immunoglobulin within 3 months before vaccination. * have acute illness or are in the acute exacerbation phase of a chronic disease within 3 days before vaccination. * allergic history to any vaccine-related component; history of severe allergies to any vaccine. * history of convulsions, epilepsy or encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, damage to nerve tissue in brain caused by chemical drug poisoning, etc.) and psychiatric history or family history of mental illness. * asplenia or functional asplenia, and asplenia or splenectomy caused by any reason. * primary or secondary immunocompromised or diagnosed with congenital or acquired immunodeficiency, infection of hiv, lymphoma, leukemia, sle, jra, inflammatory bowel disease or other autoimmune diseases. * received immunosuppressive therapy (such as long-term application of systemic glucocorticoids ≥ 14 days, dose ≥ 2 mg/kg/day or prednisone ≥ 20mg/day or equivalent to that dose of prednisone, excluding inhaled, intra-articular and topical steroid) within 3 months before vaccination. * serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), liver and renal diseases and diabetes with complications. * history of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection. * abnormal blood pressure (systolic blood pressure ≥ 140mmhg and/or diastolic blood pressure ≥ 90mmhg) before vaccination; abnormal ecg * laboratory indicators out of the specified ranges (i.e., out of 1.5x of uln or lln), or with clinical significance as judged by the physician. * current/long-term history of alcohol abuse and/or history of drug abuse. * any other factors judged by investigator that may affect the safety of the subject or evaluation of the study.

Keywords: herpes zoster vaccine bv211
ddn in stroke--cobre

Conditions: Stroke; Spasticity, Muscle; CVA

Summary: the study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. in people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). the purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. it is intended to release a knot in the muscle and relieve pain. the total study duration is 7 visits over 2 weeks. there will be 4 visits the first week, and 3 visits the second week. the first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. the second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. dry needling will take place on the fifth visit only. during each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.


Eligibility criteria:
inclusion criteria: * ≥18 years old * no known neurological injuries. * neurologically stable for \>6 months (and \>1 yr post stroke) * medical clearance to participate * unilateral ankle and/or wrist spasticity, confirmed by modified ashworth scale (mas) \> 1 and the presence of spastic hyperreflexia exclusion criteria: * motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation * a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension) * a medically unstable condition (including temporary infections and pregnancy) * age \<18 years old * cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol * metal allergies * needle phobias * lymphedema over a limb (due to risk of infection/cellulitis) * abnormal bleeding tendencies * compromised immune system * vascular disease * uncontrolled diabetes * history of epilepsy (as ddn generates strong somatosensory sensation) * anxiety disorders or in distress * botox injection in target muscle within 3 months prior to start of study

Keywords: dry needling nervous system central nervous system reflexes
pathophysiology of chronic wounds

Conditions: Healthy; Skin Ulcer

Summary: this study will compare blood from healthy volunteers and with wound fluid and tissue samples from patients with acute and chronic wounds enrolled in other nih studies. chronic wounds, such as venous leg ulcers, pressure sores, ischemic ulcers and diabetic foot ulcers, affect more than 4 million americans each year and cost about $9 billion to treat. the nature of these wounds is not well understood and treatments are not always successful, for unknown reasons. blood collected from healthy volunteers will be used to prepare a model for studying various processes involved in wound healing. normal healthy volunteers 21 years of age and older who do not smoke and have no medical problems of the heart, bones, muscles, stomach, lungs, blood, or nervous system, do not have problems going to the bathroom, and have no infections may be eligible for this study. participants will be interviewed briefly for information on their date of birth, gender, ethnic identity and medical history and will have a brief physical examination, including a check of height and weight, vital signs and heart and lung sounds. about 14 milliliters (2 tablespoons) of blood will be drawn from the arm.

chronic wounds are "any interruption on the continuity of the body's tissue that requires a prolonged time to heal, does not heal, or recurs" (wysocki, 1996). venous leg ulcers, pressure sores, ischemic ulcers, and diabetic foot ulcers are examples of chronic wounds. these kinds of wounds affect over 4 million americans each year and cost over $9 billion to treat. the pathophysiology of these wounds is not well understood and therapies directed at healing these wounds are not always successful for unknown reasons. to better understand the pathophysiology of these wounds we propose to collect blood by venipuncture from healthy volunteers. blood will be used to prepare blood and plasma derived serum for use in an in vitro wound healing model and boyden chamber assays to study cell migration, adhesion, genetic expression, expression of cell surface receptors, and protein expression to construct a profile of various healing processes. this baseline data will be used for studying the effect of acute and chronic wound fluids on cell migration, adhesion, genetic expression, expression of cell surface receptor and protein expression in an in vitro wound model (protocols to be submitted for each patient population).

Eligibility criteria:
inclusion criteria healthy volunteers, 21 years of age and older. male or female. exclusion criteria volunteers with known neurological, cardiac, endocrine, skeletal, gastrointestinal, immunological, neoplastic, pulmonary, urologic, hematologic, or infectious disease. volunteers taking medications to treat a known diagnosed illness. smoker. children will not be used because chronic wounds are rarely seen in this population.

Keywords: mmp proteases adhesion migration extracellular matrix
study of telotristat etiprate (lx1606) in participants with symptomatic carcinoid syndrome

Conditions: Carcinoid Syndrome

Summary: the purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (lx1606) in participants with symptomatic carcinoid syndrome.


Eligibility criteria:
inclusion criteria: * males and females, aged 18 and older * biopsy-proven metastatic carcinoid tumor of the gastrointestinal (gi) tract with disease extent confirmed by computed tomography (ct), magnetic resonance imaging (mri), or radionuclide imaging * symptomatic carcinoid syndrome (≥4 bowel movements per day) * ability to provide written informed consent exclusion criteria: * ≥ 12 high-volume, watery bowel movements per day * sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening * karnofsky status ≤70% - unable to care for self * surgery within 60 days prior to screening * a history of short bowel syndrome * life expectancy \< 12 months * history of substance or alcohol abuse within 2 years prior to screening * administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after localized prostatic cancer treatment.

Conditions: Rectourethral Fistula

Summary: prostate cancer is the first cancer amongst men with more than 50000 cases per year in france. surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (\<1%) of localized prostatic cancer treatment but hard to manage. different types of treatment exist: conservatory, trans-sphinteric (york-masson), transanal, perineal, with or without muscle flap interposition. gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce. the aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.


Eligibility criteria:
inclusion criteria: * male over 18 years old * treated for a localized prostatic cancer (prostatectomy, cryotherapy, hifu, radiotherapy) * affected with a treatment induced rectourethral fistula exclusion criteria: * rectourethral fistula caused by other pelvic diseases (gynecological or digestif cancer, inflammatory bowel disease, other urogenital issues) * rectourethral fistula treated by cysto-prostatectomy with urinary tract derivation * patient under guardianship * non comprehension of written or spoken french

Keywords: rectourethral fistula gracilis flap prostate cancer
an optional investigation of biomarkers of efficacy

Conditions: Rhinoconjunctivitis

Summary: house dust mites (hdm) are arachnids that infest bedding, carpet, upholstered furniture and fabric. like many other allergens, exposure to hdma in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. in contrast to other allergens, there is evidence that hdma leads to the development of asthma, in addition to exacerbating pre-existing asthma in hdm-sensitised patients. toleromune house dust mite (tm-hdm) is being developed for the treatment of hdm allergy. study th002 evaluated the efficacy, safety and tolerability of tm-hdm. this study will identify cellular, proteomic or genetic biomarkers of efficacy to tm-hdm treatment in th002 study participants


Eligibility criteria:
inclusion criteria: * previously randomised into study th002, completed the study and received either placebo or the 12 nmol dose in th002. exclusion criteria: * subjects who have received allergen or peptide immunotherapy during the last 12 months (other than tm-hdm)

Keywords: house dust mite rhinoconjunctivitis toleromune
the effect of anesthetics agents on vascular injury and level of syndecan-1 during knee surgery

Conditions: Ischemia

Summary: ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx. the purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.

the patients were allocated randomly to receive propofol or desflurane. also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order. 1. preoperation (immediate before anesthesia induction) 2. immediate before tourniquet off 3. 5 min after tourniquet off 4. pacu 5. postoperative 6 hours 6. postoperative 24 hours serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay

Eligibility criteria:
inclusion criteria: * patients who was planned to undergo knee surgery. exclusion criteria: * age \< 20 years old * history of previous cancer * history of previous peripheral vascular disease * emergency surgery
study of olaparib/trabectedin vs. doctor's choice in solid tumors

Conditions: Cancers With DNA Repair-Deficiency

Summary: evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients with locally advanced/metastatic solid tumors that failed standard treatment and whose molecular sequencing tumor profiles show homologous recombination repair (hrr) defects. the primary objective is to show superior disease control rate in patients with hrr-deficient tumors treated with olaparib and trabectedin compared to treatment according to current guidelines (physician's choice). this trial aims to establish whether the parp-dependency of hrr-deficient tumors across entities can be exploited for therapeutic benefit.


Eligibility criteria:
main inclusion criteria: * written informed consent * progressive locally advanced or metastatic malignancy * prior administration of standard treatment for primary and relapsed malignancy * eastern cooperative oncology group performance status ≤1 * patients with central venous access device in place (central venous catheter or porta-cath) * age ≥18 and ≤70 years * identification of defective dna repair via hr * adequate bone marrow, renal, and hepatic function * hemoglobin ≥10 g/dl * neutrophil count ≥1,500/mm3 * platelet count ≥100,000/µl * bilirubin ≤1.5 x upper limit of normal (uln) * alt and ast ≤2.5 x uln (≤5 x uln in patients with hepatic tumor involvement) * alkaline phosphatase ≤2.5 x uln * pt-inr/ptt ≤1.5 x uln * albumin ≥25 g/l * creatine kinase ≤2.5 x uln * serum creatinine 1.5 mg/dl or creatinine clearance 51 ml/min main exclusion criteria: * hematological malignancies and primary brain tumors. * concurrent treatment in another interventional clinical trial * prior treatment with parp inhibitors * patients with platinum-refractory disease, defined as progressive disease during or immediately after treatment with platinum based chemotherapy * persistent toxicity (\> grade 2 according to ctcae 5.0) * dementia or significant impairment of cognitive state * history of hiv infection * clinical signs of active infection (\>grade 2 according to ctcae 4.03) * history of viral hepatitis (hbv or hcv) * epilepsy requiring pharmacologic treatment * pregnancy * major surgical intervention 4 weeks prior to study inclusion * known hypersensitivity to any of the study drugs * hematologic malignancy * qtc time prolongation \>500 ms or history of familial long-qt-syndrome * heart failure nyha iii/iv * severe obstructive or restrictive ventilation disorder * concomitant use of known strong cyp3a inhibitors * concomitant use of known strong cyp3a inducers
impact of ascorbic acid on post-cardiothoracic surgery inflammation

Conditions: Cardiac Surgery; Inflammation

Summary: the purpose of this study is to see if ascorbic acid (vitamin-c) therapy will reduce inflammation following heart surgery.

atrial fibrillation is a significant cause of morbidity following cardiothoracic surgery. despite prophylactic therapy with beta-blockers and amiodarone, post-operative atrial fibrillation occurs in approximately 22% of patients. we believe that by reducing the inflammation that is caused during cts, we can see further improvements without any negative effects on hemodynamics. ascorbic acid, a free radical scavenger has been found to lower inflammation mediators but never in a cts population. this study will help determine the affect of ascorbic acid on the inflammation associated with cts.

Eligibility criteria:
inclusion criteria: * cardiothoracic surgery exclusion criteria: * pregnancy * prior hypersensitivity to ascorbic acid * renal calculi

Keywords: atrial fibrillation cardiac surgery ascorbic acid vitamin-c inflammation
permanent atrial fibrillation outcome study using dronedarone on top of standard therapy

Conditions: Atrial Fibrillation

Summary: primary objective: * demonstrate the efficacy of dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent atrial fibrillation \[af\] and additional risk factors secondary objective: * demonstrate the efficacy of dronedarone in preventing cardiovascular death this was an event-driven study where a common study end date \[csed\] was to be determined by steering committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

the study period per participant was variable depending on the enrollment in the study. a final follow-up visit had to occur within 1 month after the csed.

Eligibility criteria:
inclusion criteria: * permanent af defined by the presence of all of the following criteria: * availability of one 12-lead ecg not more than 14 days prior to randomization showing that the patient is in af or atrial flutter; * availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in af or atrial flutter at least 6 months prior to randomization; * no evidence of sinus rhythm in the period between these two documentations of af; * decision of the patient and physician to allow af to continue without further efforts to restore sinus rhythm. * at least one of the following risk criteria: * coronary artery disease; * prior stroke or transient ischemic attack \[tia\]; * symptomatic heart failure; * left ventricular ejection fraction \[lvef\] less or equal to 0.40; * peripheral arterial occlusive disease; * aged 75 years or older with both hypertension and diabetes mellitus. exclusion criteria: * paroxysmal af; * persistent af without a decision to allow af to continue without further efforts to restore sinus rhythm; * heart failure of new-york heart association \[nyha\] class iv or recent unstable nyha class iii. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
mechanism research of tinnitus based on electroencephalogram and acoustic therapy intervention

Conditions: Tinnitus, Subjective

Summary: this project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

tinnitus is one of the most common auditory disturbances in human. the treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. with the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. the possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. eeg, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. changes in activity in auditory brain areas associated with tinnitus have been observed using eeg/erps, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. this project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

Eligibility criteria:
inclusion criteria: 1. 18-30 years old, male or female; 2. pta (0.5,1,2khz) ≤25db hl; 3. tinnitus is a major problem faced by patients (except healthy volunteers); 4. tinnitus course \> for 3 months; 5. healthy, no history of other ear diseases, no history of hearing impairment; 6. there are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment; 7. voluntary tinnitus treatment, and have enough time to cooperate with treatment. exclusion criteria: 1. pulsatile tinnitus; 2. acute tinnitus; 3. tinnitus is associated with severe hearing loss; 4. tinnitus accompanied by vertigo; 5. tinnitus accompanied by headache; 6. tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder; 7. post-traumatic tinnitus; 8. tinnitus is associated with serious psychiatric complications;